ADVIL

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Advil Adverse Events Reported to the FDA Over Time

How are Advil adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Advil, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Advil is flagged as the suspect drug causing the adverse event.

Most Common Advil Adverse Events Reported to the FDA

What are the most common Advil adverse events reported to the FDA?

Drug Ineffective	2420 (4.79%)
Completed Suicide	1560 (3.09%)
Drug Toxicity	740 (1.46%)
Overdose	731 (1.45%)
Vomiting	613 (1.21%)
Cardiac Arrest	548 (1.08%)
Death	512 (1.01%)
Nausea	511 (1.01%)
Dizziness	505 (1%)
Cardio-respiratory Arrest	489 (.97%)
Respiratory Arrest	475 (.94%)
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Somnolence	472 (.93%)
Dyspnoea	465 (.92%)
Headache	461 (.91%)
Hypersensitivity	429 (.85%)
Urticaria	424 (.84%)
Condition Aggravated	405 (.8%)
Insomnia	399 (.79%)
Pruritus	380 (.75%)
Malaise	367 (.73%)
Abdominal Pain Upper	352 (.7%)
Rash	349 (.69%)
Intentional Overdose	348 (.69%)
Intentional Drug Misuse	306 (.61%)
Incorrect Dose Administered	298 (.59%)
Feeling Abnormal	284 (.56%)
Drug Effect Decreased	280 (.55%)
Heart Rate Increased	280 (.55%)
Pain	280 (.55%)
Fatigue	279 (.55%)
Swelling Face	278 (.55%)
Diarrhoea	255 (.5%)
Loss Of Consciousness	252 (.5%)
Blood Pressure Increased	241 (.48%)
Erythema	241 (.48%)
Suicide Attempt	241 (.48%)
Convulsion	240 (.47%)
Drug Abuse	236 (.47%)
Pyrexia	234 (.46%)
Abdominal Discomfort	233 (.46%)
Hypotension	216 (.43%)
Tachycardia	204 (.4%)
Renal Failure Acute	203 (.4%)
Agitation	199 (.39%)
Oedema Peripheral	197 (.39%)
Multiple Drug Overdose	194 (.38%)
Chest Pain	193 (.38%)
Drug Interaction	193 (.38%)
Hypertension	192 (.38%)
Anxiety	188 (.37%)
Asthenia	186 (.37%)
Tremor	178 (.35%)
Drug Dependence	175 (.35%)
Palpitations	171 (.34%)
Accidental Overdose	168 (.33%)
Multiple Drug Overdose Intentional	168 (.33%)
Eye Swelling	167 (.33%)
Poisoning	161 (.32%)
Lip Swelling	154 (.3%)
Drug Hypersensitivity	151 (.3%)
Alanine Aminotransferase Increased	150 (.3%)
Drug Administration Error	138 (.27%)
Dysphagia	135 (.27%)
Poor Quality Drug Administered	135 (.27%)
Hyperhidrosis	131 (.26%)
Coma	126 (.25%)
Medication Error	126 (.25%)
Blood Glucose Increased	124 (.25%)
Product Quality Issue	124 (.25%)
Hallucination	122 (.24%)
Myalgia	122 (.24%)
Nasal Congestion	122 (.24%)
Blister	120 (.24%)
Aspartate Aminotransferase Increase...	119 (.24%)
Renal Failure	119 (.24%)
Restlessness	118 (.23%)
Abdominal Pain	115 (.23%)
Constipation	115 (.23%)
Dehydration	115 (.23%)
Pulmonary Oedema	115 (.23%)
Accidental Drug Intake By Child	112 (.22%)
Back Pain	112 (.22%)
Confusional State	111 (.22%)
Depression	111 (.22%)
Pain In Extremity	111 (.22%)
Cough	110 (.22%)
Throat Irritation	108 (.21%)
Hypoaesthesia	106 (.21%)
Inflammation	106 (.21%)
Chest Discomfort	105 (.21%)
Dysarthria	103 (.2%)
Unresponsive To Stimuli	103 (.2%)
White Blood Cell Count Increased	103 (.2%)
Epistaxis	101 (.2%)
Fall	100 (.2%)
Rash Erythematous	100 (.2%)
Blood Pressure Decreased	98 (.19%)
Chills	98 (.19%)
Pneumonia	98 (.19%)
Haematemesis	96 (.19%)
Dyspepsia	95 (.19%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Advil, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Advil is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Advil

What are the most common Advil adverse events reported to the FDA?

Therapeutic And Nontherapeutic Effe...	3159 (6.25%)
Medication Errors	2932 (5.8%)
Neurological	2666 (5.27%)
Epidermal And Dermal Conditions	2525 (4.99%)
Gastrointestinal Signs	2368 (4.68%)
Suicidal And Self-injurious Behavio...	1927 (3.81%)
Respiratory	1894 (3.75%)
Cardiac Arrhythmias	1762 (3.49%)
Chemical Injury And Poisoning	1085 (2.15%)
Cardiac And Vascular Investigations	1038 (2.05%)
Infections - Pathogen Unspecified	942 (1.86%)
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Psychiatric	907 (1.79%)
Allergic Conditions	744 (1.47%)
Fatal Outcomes	626 (1.24%)
Hematology Investigations	616 (1.22%)
Hepatic And Hepatobiliary	595 (1.18%)
Anxiety Disorders	580 (1.15%)
Sleep Disorders	562 (1.11%)
Renal Disorders	530 (1.05%)
Oral Soft Tissue Conditions	525 (1.04%)
Headaches	520 (1.03%)
Injuries	508 (1%)
Hepatobiliary	495 (.98%)
Angiedema And Urticaria	470 (.93%)
Upper Respiratory Tract Disorders	446 (.88%)
Gastrointestinal Motility And Defec...	445 (.88%)
Muscle	436 (.86%)
Gastrointestinal Hemorrhages	420 (.83%)
Movement Disorders	404 (.8%)
Musculoskeletal And Connective Tiss...	403 (.8%)
Disturbances In Thinking	398 (.79%)
Bacterial Infectious	389 (.77%)
Metabolic, Nutritional And Blood Ga...	366 (.72%)
Seizures	365 (.72%)
Eye	337 (.67%)
Cardiac Disorder Signs	332 (.66%)
Lower Respiratory Tract Disorders	322 (.64%)
Urinary Tract Signs	311 (.62%)
Decreased And Nonspecific Blood Pre...	301 (.6%)
Body Temperature Conditions	300 (.59%)
Physical Examination Topics	296 (.59%)
Product Quality Issues	281 (.56%)
Deliria	276 (.55%)
Toxicology And Therapeutic Drug Mon...	263 (.52%)
Electrolyte And Fluid Balance Condi...	259 (.51%)
Joint	242 (.48%)
Water, Electrolyte And Mineral	236 (.47%)
Gastrointestinal Ulceration And Per...	224 (.44%)
Vision	224 (.44%)
Skin Appendage Conditions	222 (.44%)
Tongue Conditions	221 (.44%)
Renal And Urinary Tract Investigati...	220 (.44%)
Lifestyle Issues	217 (.43%)
Vascular Hypertensive	216 (.43%)
Ocular Infections, Irritations And ...	215 (.43%)
Mental Impairment	213 (.42%)
Vascular	199 (.39%)
Mood Disorders	194 (.38%)
Viral Infectious	185 (.37%)
Central Nervous System Vascular	172 (.34%)
Appetite And General Nutritional	171 (.34%)
Ocular Neuromuscular	171 (.34%)
Enzyme	170 (.34%)
Depressed Mood Disorders	165 (.33%)
Procedural And Device Related Injur...	165 (.33%)
Gastrointestinal Inflammatory Condi...	164 (.32%)
White Blood Cell	159 (.31%)
Coronary Artery	148 (.29%)
Acid-base	141 (.28%)
Personality Disorders	140 (.28%)
Changes In Physical Activity	139 (.27%)
Bronchial Disorders	130 (.26%)
Gastrointestinal Conditions	130 (.26%)
Anemias Nonhemolytic And Marrow Dep...	124 (.25%)
Inner Ear And Viiith Cranial Nerve	108 (.21%)
Psychiatric And Behavioural Symptom...	106 (.21%)
Skin Vascular Abnormalities	104 (.21%)
Pleural	103 (.2%)
Spleen, Lymphatic And Reticulendoth...	103 (.2%)
Vascular Hemorrhagic	101 (.2%)
Therapeutic Procedures And Supporti...	100 (.2%)
Salivary Gland Conditions	95 (.19%)
Neuromuscular	88 (.17%)
Schizophrenia And Other Psychotic	88 (.17%)
Administration Site Reactions	84 (.17%)
Tissue	82 (.16%)
Malabsorption Conditions	79 (.16%)
Glucose Metabolism Disorders	77 (.15%)
Protein And Chemistry Analyses	74 (.15%)
Encephalopathies	72 (.14%)
Bone Disorders	71 (.14%)
Platelet	71 (.14%)
Nephropathies	70 (.14%)
Heart Failures	69 (.14%)
Dental And Gingival Conditions	64 (.13%)
Myocardial	64 (.13%)
Neonatal And Perinatal Conditions	64 (.13%)
Legal Issues	59 (.12%)
Increased Intracranial Pressure And...	58 (.11%)
Embolism And Thrombosis	56 (.11%)
Hematological And Lymphoid Tissue T...	56 (.11%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Advil, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Advil is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Advil According to Those Reporting Adverse Events

Why are people taking Advil, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication	1795
Product Used For Unknown Indication	1685
Pain	1541
Headache	1301
Premedication	1267
Insomnia	722
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Pyrexia	676
Nasopharyngitis	559
Back Pain	547
Suicide Attempt	467
Nasal Congestion	395
Arthralgia	381
Hypersensitivity	327
Arthritis	324
Prophylaxis	259
Pain In Extremity	212
Migraine	207
Sleep Disorder	204
Pruritus	187
Toothache	158
Sinus Disorder	151
Cough	144
Analgesic Therapy	143
Sinus Headache	143
Myalgia	133
Influenza	121
Sinus Congestion	111
Ill-defined Disorder	103
Sinusitis	101
Musculoskeletal Pain	99
Dysmenorrhoea	97
Osteoarthritis	94
Rhinitis	82
Preoperative Care	82
Intentional Overdose	76
Rash	72
Seasonal Allergy	68
Hypotension	62
Neck Pain	60
Inflammation	60
Multiple Allergies	60
Upper Respiratory Tract Infection	57
Rhinorrhoea	57
Muscle Spasms	56
Accidental Exposure	55
Mydriasis	54
Oropharyngeal Pain	49
Completed Suicide	49
Influenza Like Illness	48
Rheumatoid Arthritis	45
Cataract Operation	42

Drug Labels

Label	Labeler	Effective
Childrens Advil Cold	Pfizer Consumer Healthcare	30-JUN-10
Advil Migraine	Pfizer Consumer Healthcare	30-JUN-10
Junior Strength Advil	Pfizer Consumer Healthcare	22-JUN-11
Advil Allergy Sinus	Pfizer Consumer Healthcare	29-JUN-11
Advil Pm	Pfizer Consumer Healthcare	30-JUN-11
Advil Cold And Sinus	Pfizer Consumer Healthcare	30-JUN-11
Junior Strength Advil	Pfizer Consumer Healthcare	01-JUL-11
Advil	Pfizer Consumer Healthcare	10-AUG-11
Advil Cold And Sinus	Pfizer Consumer Healthcare	27-FEB-12
Childrens Advil	Pfizer Consumer Healthcare	22-OCT-12
Advil	Pfizer Consumer Healthcare	22-OCT-12
Advil Pm	Lil' Drug Store Products, Inc.	27-DEC-12
Advil	Lil' Drug Store Products, Inc.	02-JAN-13
Advil Pm	Pfizer Consumer Healthcare	29-JAN-13
Advil Allergy And Congestion Relief	Pfizer Consumer Healthcare	21-MAR-13
Advil Congestion Relief	Pfizer Consumer Healthcare	21-MAR-13
Infants Advil	Pfizer Consumer Healthcare	11-APR-13

Advil Case Reports

What Advil safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Advil. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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